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Cited by 719Diabetes Treatment and ManagementPharmacology and Obesity TreatmentDiabetes, Cardiovascular Risks, and Lipoproteins

The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.

Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years

Klonoff, David C., Buse, John B., Nielsen, Loretta L., Guan, Xuesong, Bowlus, Christopher L., Holcombe, John H., Wintle, Matthew E., Maggs, David G.·2008·Current Medical Research and Opinion
DOI 10.1185/030079908x253870
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Abstract

BACKGROUND: Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes (T2DM), reduced hemoglobin A(1c) (A1C) and weight in clinical trials. The objective of this study was to evaluate the effects of > or = 3 years exenatide therapy on glycemic control, body weight, cardiometabolic markers, and safety. METHODS: Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial. Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure. Patients continued metformin and/or sulfonylureas. RESULTS: 217 patients (64% male, age 58 +/- 10 years, weight 99 +/- 18 kg, BMI 34 +/- 5 kg/m(2), A1C 8.2 +/- 1.0% [mean +/- SD]) completed 3 years of exenatide exposure. Reductions in A1C from baseline to week 12 (-1.1 +/- 0.1% [mean +/- SEM]) were sustained to 3 years (-1.0 +/- 0.1%; p < 0.0001), with 46% achieving A1C < or = 7%. Exenatide progressively reduced body weight from baseline (-5.3 +/- 0.4 kg at 3 years; p < 0.0001). Patients with elevated serum alanine aminotransferase (ALT) at baseline (n = 116) had reduced ALT (-10.4 +/- 1.5 IU/L; p < 0.0001) and 41% achieved normal ALT. Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline (-6.1 +/- 0.6 kg vs. -4.4 +/- 0.5 kg; p = 0.03), however weight change was minimally correlated with baseline ALT (r = -0.01) or ALT change (r = 0.31). Homeostasis Model Assessment B (HOMA-B), blood pressure, and aspartate aminotransferase (AST) all improved. A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis (n = 151). Triglycerides decreased 12% (p = 0.0003), total cholesterol decreased 5% (p = 0.0007), LDL-C decreased 6% (p < 0.0001), and HDL-C increased 24% (p < 0.0001). Exenatide was generally well tolerated. The most frequent adverse event was mild-to-moderate nausea. The main limitation of this study is the open-label, uncontrolled nature of the study design which does not provide a placebo group for comparison. CONCLUSION: Adjunctive exenatide treatment for > or = 3 years in T2DM patients resulted in sustained improvements in glycemic control, cardiovascular risk factors, and hepatic biomarkers, coupled with progressive weight reduction.

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Crossref · 10.1185/030079908x253870

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Metadata

Authors
Klonoff, D. C., Buse, J. B., Nielsen, L. L., Guan, X., Bowlus, C. L., Holcombe, J. H., Wintle, M. E., & Maggs, D. G.
Affiliations
  • Mills Peninsula Health Services (US)
  • University of North Carolina at Chapel Hill (US)
  • Amylin Pharmaceuticals, Inc. San Diego, CAUSA
  • University of California, Davis (US)
  • Eli Lilly (United States) (US)
Corresponding author
Nielsen, Loretta L.
ORCID
Venue
Current Medical Research and Opinion
Publisher
Informa UK Limited
Published
2007-12-03
Volume
24
Issue
1
Pages
275-286
ISSN
  • 0300-7995 (ISSN-L)
  • 1473-4877
DOI
10.1185/030079908x253870
OpenAlex
W2070710390
Cited by
699
References
37
Citations by year
2025: 16 · 2024: 4 · 2023: 6 · 2022: 11 · 2021: 18 · 2020: 15 · 2019: 8 · 2018: 16 · 2017: 20 · 2016: 33 · 2015: 37 · 2014: 49 · 2013: 69 · 2012: 90
FWCI
49.69
Type
journal article
Language
en
Open access
closed
Locations
  • Current Medical Research and Opinion (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
exenatide, GLP-1 receptor agonists, type 2 diabetes, glycemic control, HbA1c, weight loss, obesity, cardiovascular risk factors, alanine aminotransferase, hepatic safety, long-term treatment, metformin, sulfonylureas, HOMA, LDL cholesterol, triglycerides, LDL/HDL ratio
MeSH terms
Exenatide, Aged, Blood Pressure, Body Weight, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Liver, Male, Middle Aged, Obesity, Peptides, Placebos, Risk Factors, Time Factors, Venoms, Biomarkers, Pharmacological

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